Escarpilo 400 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Escarpilo 400 mg tablets EFG

eslicarbazepine, acetate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Escarpilo is and what it is used for
2. What you need to know before taking Escarpilo
3. How to take Escarpilo
4. Possible adverse effects
5. How to store Escarpilo
6. Contents of the pack and other information

1. What Escarpilo is and what it is used for

This medicine contains the active substance eslicarbazepine acetate.

This medicine belongs to a group of medicines called antiepileptics, used to treat epilepsy, a condition in which affected individuals experience repeated seizures or convulsive fits.

This medicine is used:

• as a single medicine (monotherapy) in adult patients with newly diagnosed epilepsy;
• together with other antiepileptic medicines (adjunctive therapy) in adult, adolescent, and pediatric patients over 6 years of age who experience epileptic seizures (convulsions) originating in one part of the brain (partial seizures). These seizures may or may not be followed by a seizure affecting the entire brain (secondary generalization).

Your doctor has prescribed this medicine to reduce the number of seizures.

2. What you need to know before starting to take Escarpilo

Do not take Escarpilo:

• if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (for example carbamazepine or oxcarbazepine, medicines used to treat epilepsy), or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a certain type of heart rhythm disorder (second- or third-degree atrioventricular (AV) block).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Inform your doctor immediately:

• if you develop blisters or peeling of the skin and/or mucous membranes, rash, difficulty swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These could be signs of an allergic reaction;
• if you experience confusion, worsening of seizures, or decreased level of consciousness, which could be signs of low blood levels of salts.

Inform your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. This medicine is not recommended for patients with severe renal disease;
• if you have liver problems. This medicine is not recommended for patients with severe liver problems;
• if you are taking any medicine that may cause an abnormality in the ECG (electrocardiogram) known as PR interval prolongation. If you are unsure whether the medicines you are taking may cause this effect, discuss this with your doctor;
• if you have any heart conditions such as heart failure or heart attack, or have any disturbances in heart rhythm;
• if you have seizures that begin with a generalized electrical discharge affecting both sides of the brain.

A small number of people taking antiepileptic medicines have had thoughts of self-harm or suicide. If this happens to you while taking this medicine, contact your doctor immediately.

This medicine may cause dizziness and/or drowsiness, especially at the beginning of treatment. Exercise particular caution while taking this medicine to avoid accidental injury, such as falls.

Take special care with this medicine.

In post-marketing experience, serious and potentially life-threatening skin reactions have been reported in patients treated with this medicine, including Stevens-Johnson Syndrome / toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS).

If you develop a severe rash or other skin symptom (see section 4), stop taking this medicine and consult your doctor or seek immediate medical attention.

In patients of Thai origin and the Han Chinese ethnic group, the risk of serious skin reactions associated with carbamazepine or chemically related compounds can be predicted by a blood test in these patients. Your doctor may advise you about the need for such a blood test before starting this medicine.

Children

This medicine must not be given to children aged 6 years or younger.

Other medicines and escarpilo

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This recommendation is in case any of them interfere with how this medicine works, or if this medicine interferes with the effect of those medicines. Inform your doctor if you are taking:

• phenytoin (a medicine used to treat epilepsy), as you may need to adjust the dose;
• carbamazepine (a medicine used to treat epilepsy), as you may need to adjust the dose, and the following adverse effects of this medicine may occur more frequently: double vision, abnormal coordination, and dizziness;
• hormonal contraceptives (such as birth control pills), as this medicine may reduce their effectiveness;
• simvastatin (a medicine used to lower cholesterol levels), as you may need to adjust the dose;
• rosuvastatin, a medicine used to lower cholesterol levels;
• the anticoagulant warfarin;
• tricyclic antidepressants, for example amitriptyline;
• do not take oxcarbazepine (a medicine used to treat epilepsy) together with this medicine, as it is unknown whether it is safe to take these two medicines together.

See the section “Pregnancy and breastfeeding” for recommendations regarding contraception.

Pregnancy and breastfeeding

Escarpilo is not recommended during pregnancy, as the effects of this medication on pregnancy and the developing child are unknown.

If you are planning to become pregnant, speak with your doctor before stopping your contraceptive method and before becoming pregnant. Your doctor may decide to change your treatment.

There is limited data on the use of eslicarbazepine acetate in pregnant women. Studies have shown an increased risk of congenital malformations and neurological development problems (brain development) in children of women taking antiepileptic medicines, particularly when more than one antiepileptic medicine is taken at the same time.

If you are or think you might be pregnant, inform your doctor immediately. You must not stop taking your medication without first discussing it with your doctor. Stopping your medication without medical advice may trigger seizures, which could be dangerous for you and your unborn child. Your doctor may decide to change your treatment.

If you are a woman of childbearing potential and are not planning to become pregnant, you should use an effective method of contraception during treatment with Escarpilo.

This medicine may affect the effectiveness of hormonal contraceptives, such as the oral contraceptive pill, making them less effective in preventing pregnancy.

Therefore, you are advised to use other forms of safe and effective contraception while taking Escarpilo.

Talk to your doctor, who will discuss with you the most appropriate type of contraception to use while taking this medicine. If treatment with this medicine is discontinued, you should continue using an effective method of contraception until the end of the current menstrual cycle.

If you take Escarpilo during pregnancy, your baby may also be at risk of bleeding problems immediately after birth. Your doctor may give you and your baby a medication to prevent this.

Do not breast-feed while taking this medicine. It is unknown whether this medicine passes into breast milk.

Driving and operating machinery

This medicine may cause dizziness, vertigo, and affect your vision, particularly at the start of treatment. If this occurs, do not drive or operate any tools or machinery.

This medicine contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially "sodium-free".

3. How to take Escarpilo

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults

Initial dose at the start of treatment

400 mg once daily for one or two weeks before increasing to the maintenance dose. Your doctor will decide whether you should receive this dose for one or two weeks.

Maintenance dose

The usual maintenance dose is 800 mg once daily.

Depending on your response to this medicine, the dose may be increased to 1,200 mg once daily. If you are taking eslicarbazepine alone (monotherapy), your doctor may consider increasing your dose to 1,600 mg once daily.

Patients with kidney problems

If you have kidney problems, you will generally be given a lower dose of this medicine. Your doctor will determine the correct dose for you. This medicine is not recommended if you have severe kidney problems.

Elderly patients (over 65 years of age)

If you are an elderly person and are taking this medication as monotherapy, the 1,600 mg dose is not suitable for you.

Children over 6 years of age

Starting dose

The starting dose is 10 mg per kg of body weight once daily for one or two weeks, before increasing to the maintenance dose.

Maintenance dose

Depending on the response to this medicine, the dose may be increased by 10 mg per kg of body weight, at intervals of one or two weeks, up to a maximum of 30 mg per kg of body weight. The maximum dose is 1,200 mg once daily.

Children ≥ 60 kg

Children with a body weight of 60 kg or more should take the same dose as adults.

Form and route of administration

This medicine is administered orally. Swallow the tablet with a glass of water. This medicine may be taken with or without food.

If you have difficulty swallowing the tablet whole, you may crush it and mix it with water or apple sauce, and take it immediately.

The tablet may be divided into equal doses.

If you take more Escarpilo than you should

If you accidentally take more Escarpilo than you should, you may be at risk of having more attacks, or you may feel that your heartbeat is irregular or faster than normal. Contact your doctor or go immediately to a hospital if you experience any of these symptoms. Take the medicine package with you so the doctor knows what you have taken.

You can also call the Toxicology Information Service at phone number 915620420, indicating the medication and the amount ingested.

If you forget to take Escarpilo

If you forget to take a tablet, take it as soon as you remember, and then continue taking it as usual. Do not take a double dose to make up for missed doses.

If you interrupt treatment with Escarpilo

Do not suddenly stop taking the tablets. If you do, you may be at risk of having more seizures. Your doctor will decide for how long you should take this medicine. If your doctor decides to discontinue this medicine, your dose will usually be gradually reduced. It is important that you complete the treatment as instructed by your doctor; otherwise, your symptoms may worsen.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

The following adverse effects may be very serious. If any of these occur, stop taking this medicine immediately and contact a doctor or go to a hospital straight away, as you may require urgent medical treatment:

• blistering or peeling of the skin and/or mucous membranes, rash, difficulty swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue. These could be signs of an allergic reaction.

Very common adverse effects (may affect more than 1 in 10 people) are:

• dizziness or drowsiness

Common adverse effects (may affect up to 1 in 10 people) are:

• feeling unsteady, or as if spinning or floating
• nausea or vomiting
• headache
• diarrhoea
• double or blurred vision
• difficulty concentrating
• feeling tired or lacking energy
• tremor
• skin rash
• blood tests showing low sodium levels
• loss of appetite
• difficulty sleeping
• problems with coordination of movement (ataxia)
• weight gain

Uncommon adverse effects (may affect up to 1 in 100 people) are:

• clumsiness of movement
• allergy
• constipation
• seizures
• underactive thyroid gland. Symptoms include decreased thyroid hormone levels (detected in blood tests), intolerance to cold, enlarged tongue, brittle thin nails or hair, and low body temperature
• liver problems (such as increased liver enzymes)
• high blood pressure or sudden marked increase in blood pressure
• low blood pressure, or decreased blood pressure upon standing
• blood tests showing low levels of salts (including chloride), or reduced number of red blood cells
• dehydration
• changes in eye movements, blurred vision, or red eyes
• falls
• heat stroke
• memory problems or forgetfulness
• crying, feeling depressed, nervousness or confusion, lack of interest or emotions
• inability to speak, write, or understand spoken or written language
• agitation
• attention deficit/hyperactivity
• irritability
• mood changes or hallucinations
• difficulty speaking
• nosebleeds
• chest pain
• tingling or numbness in any part of the body
• migraine
• burning sensation
• abnormal sensation to touch
• changes in sense of smell
• ringing in the ears
• hearing difficulty
• swelling of arms and legs
• heartburn, stomach discomfort, abdominal pain, bloating and abdominal discomfort, or dry mouth
• black stools
• swollen gums or toothache
• sweating or dry skin
• itching
• skin changes (e.g. skin redness)
• hair loss
• urinary tract infection
• general malaise, weakness, or chills
• weight loss
• muscle pain, limb pain, muscle weakness
• bone metabolism disorder
• increased bone proteins
• flushing (hot flush), cold extremities
• slower or irregular heartbeat
• extreme drowsiness
• sedation
• motor neurological disturbance where muscles contract causing twisting movements, repetitive movements, or abnormal postures. Symptoms may include tremors, pain, and cramps
• drug toxicity
• anxiety

Adverse effects with unknown frequency (cannot be estimated from available data) are:

• Reduction in platelets, increasing the risk of bleeding or bruising.
• Severe back or stomach pain (caused by inflammation of the pancreas).
• Reduction in white blood cells, making infections more likely.
• Red spots or circular lesions, often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital or eye ulcers, red and inflamed eyes, which may be preceded by fever and/or flu-like symptoms (Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis).
• Initially flu-like symptoms, facial rash, widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other systemic symptoms (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Severe allergic reaction causing swelling of the face, throat, hands, feet, ankles, or lower legs.
• Hives (itchy skin rash).
• Lethargy, confusion, muscle spasms, or a marked worsening of seizures (possible symptoms of low sodium levels in the blood due to inappropriate antidiuretic hormone (ADH) secretion).

Use of eslicarbazepine is associated with an ECG (electrocardiogram) abnormality called PR interval prolongation. Adverse effects related to this ECG abnormality may occur (e.g. fainting and slowing of the heartbeat).

Bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures have been reported with structurally related antiepileptic medicines such as carbamazepine and oxcarbazepine. Speak with your doctor or pharmacist if you are on long-term antiepileptic treatment, have a history of osteoporosis, or are taking steroids.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if they are possible adverse reactions not listed in this leaflet. You may also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Escarpilo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister, the bottle, and the carton after the letters EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Escarpilo

• The active substance is eslicarbazepine acetate. Each tablet contains 400 mg of eslicarbazepine acetate (equivalent to 343.28 mg of eslicarbazepine).
• The other components are povidone K30, sodium croscarmellose, and magnesium stearate.

Appearance of the product and contents of the pack

Escarpilo 400 mg tablets are white to off-white, oblong, biconvex (16 x 7 mm), with a score line on one side.

The tablet can be divided into equal doses.

The tablets are packed in blisters, in cardboard boxes containing 20, 28, 30, or 60 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 – Sant Joan Despí

Barcelona – Spain

Manufacturer Responsible

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

or

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Strasse 23

Langenfeld 40764

Germany

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Portugal: Escarpilo

Spain: Escarpilo 400 mg tablets EFG

Date of the most recent review of this leaflet:

December 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.